← Back to catalogue

Itotal Identity Round Patella Head Sizer 38-41-44mm

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
ITOTAL IDENTITY ROUND PATELLA HEAD SIZER 38-41-44MM FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Model / Reference
1080-218 FDA UDI

Identifiers

Primary DI / UDI-DI
00810933030643 FDA UDI
FDA Product Code
OOG FDA UDI
OIY FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Itotal Identity Round Patella Head Sizer 38-41-44mm by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI 6e02f6a2-939a-4b20-8f17-63809e7d7ae5 34 fields · synced May 30, 2026